Phase 2 Study of FB825 Treatment for Adults With Moderate-to-Severe Allergic Asthma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a drug called FB825 in adults with moderate-to-severe allergic asthma. This randomized, placebo-controlled, and double-blind Phase II study aims to compare FB825 with a placebo to better understand its impact on asthma exacerbations and lung function. The study is sponsored by Oneness Biotech Co., Ltd. and involves patients who have been diagnosed with allergic asthma for at least one year. The study includes a 4-week screening period, followed by a 24-week treatment phase and a 12-week follow-up period. Participants will be randomly assigned to receive either FB825 or placebo in equal numbers. The treatment involves an initial intravenous infusion of 8 mgkg followed by five infusions of 4 mgkg every four weeks. Patients will continue their usual asthma control medications, such as inhaled corticosteroids and long-acting beta-agonists, during the study. After the treatment phase, participants will return to combination therapy with inhaled corticosteroids and beta-agonists as needed. During the trial, patients will undergo regular assessments including lung function tests, asthma control questionnaires, and monitoring for any asthma exacerbations. Researchers will also track adverse events to evaluate safety. The main outcome measured is the occurrence of asthma exacerbations at 24 weeks after starting treatment. Additional evaluations include changes in lung function and symptom control throughout the study. The total participation duration is approximately 40 weeks, including screening, treatment, and follow-up.

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma